Upcoming Meetings

The PEDAC and EMDAC will meet to discuss the major objectives of a phase 3 drug development program indicated for the treatment of children with achondroplasia (ACH). The following elements of a phase 3 program should be considered for discussion: evidence required to establish dose-response, study design, e.g., placebo control, study duration, intended population, e.g., infants and toddlers and/or older children and adolescents, and endpoints that have a clinically meaningful impact on the patient’s functional or psychological well-being.

Past Meetings

On Monday, September 11, 2017, the Pediatric Advisory Committee (PEDAC) discussed and voted on the use of prescription opioid products for the treatment of cough in pediatric patients.

On Tuesday, September 12, 2017, the Committee discussed and voted on pediatric-focused safety reviews for certain products that are mandated by the Best Pharmaceuticals for Children Act (BPCA), the Pediatric Research Equity Act (PREA), and the Pediatric Medical Device Safety and Improvement Act (PMDSIA).

The Committees jointly supported, by a vote of 14-Yes to 0-No, with no abstentions, the use of an indwelling central venous access devices, in certain circumstances, in the clinical trial “A Double-Blind, Placebo-Controlled, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of SRP-4045 and SRP-4053 in Patients with Duchenne Muscular Dystrophy (ESSENCE).”

The Committee will discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act, the Pediatric Research Equity Act and the Pediatric Medical Device Safety and Improvement Act .

On March 6, 2017, the Committee will discuss the following products (listed by FDA Center):

Center for Drug Evaluation and Research (CDER)

a. NITROPRESS (sodium nitroprusside)

b. KUVAN (sapropterin dihydrochloride)

FDA will provide the analysis of a possible safety signal regarding the use of the drug product EXJADE (deferasirox) in children with fever and dehydration, which was discussed at the September 2015 meeting.

The Committee will also discuss the role of pharmacogenomics in pediatric product development.

On March 7, 2017, the Committtee will discuss the following products (listed by FDA Center):

The Committee discussed pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act, the Pediatric Research Equity Act, and the Pediatric Medical Device Safety and Improvement Act.

For 12 of the products that were reviewed, the Committee unanimously concurred with FDA’s proposal to continue routine surveillance. For the other products, the Committee did not have a unanimous vote or, in some cases, added or modified FDA’s recommendations.

The Committee discussed 18 pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act, the Pediatric Research Equity Act, and the Pediatric Medical Device Safety and Improvement Act of 2007. For all of the products that were reviewed, the a majority of the Committee members concurred with FDA’s proposal to continue routine surveillance.

On Monday, March 23, 2015, the Pediatric Ethics Subcommittee to the Pediatric Advisory Committee (PEDAC) discussed the general topic of how procedural sedation for nontherapeutic (research) interventions or procedures in the pediatric population should be considered under the Additional Safeguards for Children in Clinical Investigations, at 21 CFR 50 subpart D. A slight majority of the Subcommittee, 9 of 16 members, voted that there are no approaches to procedural sedation that would present no more than a minor increase over minimal risk.

On Tuesday, March 24, 2015, the PEDAC discussed pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (BPCA, Pub. L. 107-109), the Pediatric Research Equity Act (PREA, Pub. L. 108-155), and the Pediatric Medical Device Safety and Improvement Act of 2007 (PMDSIA). The PEDAC unanimously agreed with the FDA’s proposal to continue routine pharmacovigilance for the following products: QUILLIVANT XR (methylphenidate hydrochloride), LUNESTA (eszopiclone), RISPERDAL (risperidone), OXTELLAR XR (oxcarbazepine), REVATIO (sildenafil), ADVAIR HFA (fluticasone propionate/salmeterol xinafoate), DYMISTA (azelastine hydrochloride/fluticasone propionate), QNASL (beclomethasone dipropionate), VENOFER (iron sucrose), INVIRASE (saquinavir), ALTABAX Ointment (retapamulin), FluMist QUADRIVALENT (influenza vaccine live, intranasal), FLUARIX QUADRIVALENT (influenza virus vaccine), and LIPOSORBER LA-15 System. All but one of the Committee members agreed with the FDA’s proposal to continue routine pharmacovigilance for CYMBALTA (duloxetine hydrochloride). All but two of the Committee members with the FDA’s proposal to continue routine pharmacovigilance for the Medtronic ACTIVA DYSTONIA THERAPY; those two members abstained.

Mar 23, 2015 – Mar 24, 2015

Pediatric Advisory Committee (PEDAC)

PEDAC advises and makes recommendations to the FDA Commissioner regarding: